The FDA Revitalization Act — Is it Enough?

On September 27, 2007, the Food and Drug Administration Revitalization Act (“Revitalization Act”) was signed into law by President Bush. A controversial law, it has been criticized by both the pharmaceutical industry and by consumer groups who believe that it does not really address the enormous conflicts of interest created by the drug companies. Other consumer groups see the Revitalization Act as a thinly veiled attempt by the drug companies to require that vitamins and minerals be available only if approved by the FDA and they will now require a prescription.
Here are some of the chief provisions:

PUBLICATION OF CLINICAL TRIAL DATA
Before a drug can be approved for release to the public, a drug is tested on humans in Phase I, II and III clinical trials. Phase I clinical trials normally are done on approximately 100 healthy volunteers. If this trial produces acceptable results, the company goes on to Phase II. These trials generally involve 100-300 volunteers who have the condition which the drug is intended to treat. If the results of this test are acceptable, then Phase III clinical trials are started. Phase III clinical trials generally involve approximately 1,000 to 1,500 people and generally last from four to eight weeks but sometimes may extend over longer periods.

In the past ten years there has been progress in making clinical trials available to the public. It used to be that the drug company sponsoring the clinical trial had the ability to keep the very existence of the clinical trial confidential if it didn’t like the results. Therefore, if the participants in the clinical trial experienced serious side effects, this information could be kept secret. (Does this remind you of the tobacco companies and their efforts to keep secret their own studies showing the evidence of the health problems caused by tobacco?)

Dr. Grace Jackson, a psychiatrist, in her book RETHINKING PSYCHIATRIC DRUGS, summarizes the findings of a study entitled “The Emperor’s New Drugs; An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration.” Dr. Jackson states, “In conducting their meta-analysis, the research team reviewed findings of 47 short-term RCT’s (Randomized Controlled Trials) (5 Prozac, 16 Paxil, 7 Zoloft, 6 Effexor, 8 Serzone and 5 Celexa). All of these trials lasted four to eight weeks in duration……Findings were remarkable for the following:

80-90% of the antidepressant response was consistently duplicated by a placebo…

Two dose-response studies for Prozac were submitted to the FDA; one trial (mild depression) found no difference in treatment response between low and high doses; the second trial (moderate to severe depression) found lower doses to be significantly more effective than higher doses.

Three trials were conducted among severely depressed, hospitalized inpatients; two of these studies failed to detect a significant difference between active medication and placebo.”

Dr. Jackson continued, “While antidepressant enthusiasts maintain that drugs are indispensable in the treatment of severe depression, the FDA database contradicts their assertion. Two thirds of the trials conducted among hospitalized patients revealed a placebo response equal to active drug treatments. Similarly, the FDA database fails to support the argument that higher doses produce superior outcomes.”

Unfortunately, most medical professionals who prescribed these drugs and the public at large were not aware of the results of these clinical trials because there was no easily accessible database.

Most of the rest of the world, logically, has long believed that the drug company sponsoring a clinical trial of a drug has an ethical obligation to publicly acknowledge the contribution of the participants and the risk they have taken by ensuring that information about the conduct of the trial and its principal results are in the public domain.

Perhaps the most significant, and apparently most opposed by the drug companies, part of the Revitalization Act is the requirement that sponsors of all clinical trials must register their studies, at inception, in a public database sponsored by the National Library of Medicine. (However, the phase one trial of the three FDA required clinical trials is not required to be included.)

The Revitalization Act requires that the results of phase two and phase three clinical trials be posted on the internet and available to everyone. The drug companies are required to provide for posting:

Information on trial participants

Information on the outcomes for the participants

Now, despite the vociferous protests of the drug companies, clinical trials in the United States are going to be available to the public.

USER FEES

In 1992, Congress passed the Prescription Drug User Fee program which was to be renewed every five years. This law required drug companies seeking to have their new drugs approved by the FDA to pay a portion of the cost of the approval process. Since 1992, the FDA has collected in excess of $2 billion from the pharmaceutical companies.

In 2006, when Congress appropriated $219 million for the drug approval program the pharmaceutical industry fees were $304 million.

The Revitalization Act renewed the user fee program, and the FDA has announced that they expect to receive almost $400 million in fees from the pharmaceutical industry in 2008.

Consumer groups and former FDA officials maintain that these user fees actually increase, not decrease, the dependence on the drug companies and explain why more and more the FDA regards the drug companies as its clients—not the public who take the drugs. (See the August 31, 2007 Novus newsletter for more information on who the FDA represents.)

POSTMARKETING STUDIES

It is hard for most of us to imagine that the FDA really did not have the power to require postmarketing studies of drugs that were approved and released on the public. Even if there were indications of safety problems, all the FDA could do was receive reports and, if enough people died or were injured, the drug company would take the drug off the market. The need for such FDA authority was detailed in a report from the Office of Inspector General of the Department of Health and Human Services—the agency which oversees the FDA.

The Revitalization Act empowers the FDA to require postmarketing studies of drug safety. If the postmarketing studies show additional risk factors or other problems with a drug, then the FDA can now require that the drug companies change their drug labels to warn medical professionals and consumers. This is definitely better than reading about the problems with a drug in the newspaper because someone died, like what happened with Vioxx.

MISCELLANEOUS PROVISIONS

Some of the other provisions relate to:

The ability of the FDA to request changes to televised drug advertising.

The inability of the FDA to grant as many conflict-of-interest waivers to FDA advisory committee members. (Presently, many FDA committee members receive significant sums of money from drug companies whose drugs the same committees are reviewing.)

Now, for the first time, in approving new drugs, the FDA must publish its basis for approval as well as any dissenting opinions. (In the past the FDA would only publish the approval and not the dissenting opinion, which often called into question if the approved drug really did produce significantly better results (a requirement for drug approval) than existing drugs.)

CONCLUSION
There are still numerous problems with any system that has the regulated companies paying for most of the costs of the regulatory agency scrutinizing them but also allows many of the “experts” advising them to be richly compensated by the drug companies. No government agency has ever really “protected” the public. Ultimately, protection can only come if the public has “all” of the information about any area. However, given the incredible lobbying power of the drug companies, any law that requires more transparency in the activities of the FDA and the drug companies is better for the American people. The Revitalization Act is at least a start.

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